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FITME Study: Formulating Individualised Exercise Prescription in Chronic Obstructive Pulmonary Disease

NCT07792642 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-28

No results posted yet for this study

Summary

This randomised controlled trial aims to: i) compare the power output at the first metabolic threshold (WMT1) between the MT1 and the six-minute walking test (6MWT)-based cardiorespiratory exercise prescriptions in chronic obstructive pulmonary disease (COPD); ii) compare exercise adherence, peripheral muscle strength, health-related quality of life, dyspnoea, fatigue, disease impact and emotional status between MT1 and 6MWT-based exercise prescriptions.

Patients will be recruited via the pulmonology services from Unidade Local de Saúde do Baixo Mondego and Unidade Local de Saúde de Aveiro.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

OTHER

Non-pharmacological intervention: Pulmonary rehabilitation programme

Participants will undergo a supervised, in-person pulmonary rehabilitation programme lasting for twelve weeks, twice a week. The intervention comprises cardiorespiratory exercise training, conducted on either a treadmill or a cycle ergometer. Exercise intensity will be individually prescribed based on the power output registered at the first metabolic threshold, during a baseline cardiopulmonary exercise test. For treadmill exercise prescription, guideline-based estimation equations will be used to estimate treadmill velocity based on the oxygen uptake obtained in the first metabolic threshold. Resistance training will be provided in the same sessions as internationally recommended. Progress will occur on weekly basis, according to symptoms. Education and psychosocial support will also be provided once every other week. All sessions will range from 60-90 minutes.

OTHER

Non-pharmacological intervention: Pulmonary rehabilitation programme

Participants will undergo a supervised, in-person pulmonary rehabilitation programme lasting 8 to 12 weeks, twice a week. The intervention comprises cardiorespiratory exercise training, conducted on either a treadmill or a cycle ergometer. For treadmill exercise, intensity will be prescribed at 80% of the mean velocity obtained at the six-minute walking test performed at baseline. For bicycle exercise, exercise will be prescribed 80% of the mean velocity obtained at the six-minute walking test performed at baseline and peak power output estimation equations will be used. Resistance training will be provided in the same sessions as internationally recommended. Progress will occur on weekly basis, according to symptoms. Education and psychosocial support will also be provided once every other week. All sessions will range from 60-90 minutes.

Sponsors & Collaborators

  • Aveiro University

    lead OTHER

Principal Investigators

  • Alda S Marques, PhD · School of Health Sciences of the University of Aveiro (ESSUA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2029-07-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07792642 on ClinicalTrials.gov